Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-00909-1
Product Name/Description GF-UCT180 Ultrasonic Gastrovideoscope

ARTG Number: 145874
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 11/09/2015
Responsible Entity Olympus Australia Pty Ltd
Reason/Issue The nature of this product correction is to issue a revised Instruction for Use (IFU) which includes instructions on how to correctly clean the device. There is a risk of patient-to-patient infection if the device is not cleaned appropriately.

Key changes in the new Instruction for Use are highlighted below:

· Inclusion of instruction on how to attach the cleaning adapter (MAJ-350) to the instrument channel port of the GF-UCT180

· The balloon applicator (MAJ-675) and the cleaning brush (MAJ-1534) are to be reprocessed for reuse. The MAJ-675 and MAJ-1534 are to be reprocessed in accordance with step “Cleaning, disinfection, and sterilisation procedures for reusable parts and reprocessing equipment”
Recall Action Recall for Product Correction
Recall Action Instructions Olympus is advising their customers of the amendments to the IFU. Customers can request a new IFU by contacting Olympus. Hospitals are advised that a review of internal hospital protocols should be conducted to ensure compliance with the updated cleaning instructions. This action has been closed-out on 29/08/2016.
Contact Information (03) 9265 5435 - Olympus Australia